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San Diego, California--(Newsfile Corp. - September 29, 2021) - Robbins Geller Rudman & Dowd LLP announces that purchasers or acquirers of Iterum Therapeutics plc (NASDAQ: ITRM) securities between November 30, 2020 and July 23, 2021, inclusive ("Class Period") have until this upcoming Monday, October 4, 2021 to seek appointment as lead plaintiff in the Iterum class action lawsuit. The Iterum class action lawsuit charges Iterum and certain of its top executives with violations of the Securities Exchange Act of 1934. The Iterum class action lawsuit - captioned Klein v. Iterum Therapeutics plc, No. 21-cv-04181 - is pending in the Northern District of Illinois and is assigned to Judge Gary Feinerman.
If you wish to serve as lead plaintiff of the Iterum class action lawsuit, please provide your information by clicking here. You can also contact attorney J.C. Sanchez of Robbins Geller by calling 800/449-4900 or via e-mail at jsanchez@rgrdlaw.com. Lead plaintiff motions for the Iterum class action lawsuit must be filed with the court no later than this upcoming Monday, October 4, 2021.
CASE ALLEGATIONS: Iterum is a pharmaceutical company developing sulopenem, an anti-infective compound with oral and intravenous formulations that is in Phase III clinical trials for the treatment of, among other medical issues, uncomplicated urinary tract infections ("uUTIs"). In November 2020, Iterum submitted a New Drug Application ("NDA") to the U.S. Food and Drug Administration ("FDA") for sulopenem etzadroxil/probenecid (oral sulopenem) for the treatment of uUTIs in patients with a quinolone non-susceptible pathogen.
The Iterum class action lawsuit alleges that, throughout the Class Period, defendants made false and misleading statements and failed to disclose that: (i) the sulopenem NDA lacked sufficient data to support approval for the treatment of adult women with uUTIs caused by designated susceptible microorganisms proven or strongly suspected to be non-susceptible to a quinolone; (ii) accordingly, it was unlikely that the FDA would approve the sulopenem NDA in its current form; (iii) defendants downplayed the severity of issues and deficiencies associated with the sulopenem NDA; and (iv) as a result, Iterum's public statements were materially false and misleading at all relevant times.
On July 1, 2021, Iterum issued a press release "announc[ing] that the Company received a letter from the [FDA] stating that, as part of their ongoing review of the [sulopenem NDA], the agency has identified deficiencies that preclude the continuation of the discussion of labeling and post marketing requirements/commitments at this time." The press release further stated that "[n]o details with respect to deficiencies were disclosed by the FDA in this notification and the letter further states that the notification does not reflect a final decision on the information under review." On this news, Iterum's ordinary share price fell nearly 38%.